[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656615":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":41,"overallOfficials":29,"centralContacts":46,"locations":29,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":29,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":29,"enrollmentInfo":63,"targetDuration":29,"studyType":66,"phases":29,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":79,"whyStopped":29,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":29},{"fullName":5,"class":6},"Marmara University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in Baseline TAS-20 Scores Between Responders and Non-Responders","Evaluates whether baseline total alexithymia severity differs significantly between patients achieving clinical treatment response versus non-responders. Treatment response is defined as a reduction of ≥30% or ≥2 points in the 10-cm Visual Analog Scale (VAS) from baseline to 1 month post-TFESI. TAS-20 total score ranges from 20 to 100, where higher scores reflect greater alexithymia severity.","Baseline (pre-injection) compared against clinical response status evaluated at 1 month post-TFESI",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Change in Pain Intensity via Visual Analog Scale (VAS)","Measured on a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores reflect greater pain severity.","Baseline, 1 week, 1 month, and 3 months post-procedure",{"measure":19,"description":20,"timeFrame":21},"Change in Health-Related Quality of Life via SF-12","12-item health survey evaluating Physical and Mental Component Summary scores. Scores range from 0 to 100, with higher scores reflecting better health-related quality of life","Baseline, 1 month, and 3 months post-procedure",{"measure":23,"description":24,"timeFrame":25},"Baseline Psychological Symptoms via Hospital Anxiety and Depression Scale (HADS)","Assesses anxiety (HADS-A) and depression (HADS-D) subscale scores (each scored 0 to 21, higher scores indicate greater symptom severity). Used to control for confounding effects on treatment response","Baseline (immediately prior to TFESI)",{"measure":27,"description":28,"timeFrame":25},"Baseline Childhood Trauma Questionnaire (CTQ-33) Total Score","Assesses retrospective childhood maltreatment across subscales. Total scores range from 25 to 150, where higher scores reflect greater childhood trauma severity.",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","This single-center, prospective observational cohort study is conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.\n\nTransforaminal Epidural Steroid Injection (TFESI) is performed strictly based on routine clinical indications under fluoroscopic guidance (using 3 ml bupivacaine, 1 ml saline, and 1 ml betamethasone); no experimental intervention or additional procedural risk is introduced by this research protocol.\n\nEligible adult patients providing written voluntary informed consent undergo comprehensive baseline evaluations prior to injection, including:\n\n1. Sociodemographic and Clinical Questionnaire\n2. 20-Item Toronto Alexithymia Scale (TAS-20)\n3. Visual Analog Scale (VAS 0-10 cm) for pain severity\n4. Hospital Anxiety and Depression Scale (HADS)\n5. 12-Item Short Form Health Survey (SF-12)\n6. Childhood Trauma Questionnaire (CTQ-33)\n\nProspective follow-up evaluations are conducted post-procedure:\n\n* Week 1: Pain intensity via VAS\n* Month 1: Pain intensity via VAS and quality of life via SF-12\n* Month 3: Pain intensity via VAS and quality of life via SF-12\n\nTreatment response is primarily categorized at Month 1 post-injection (responder: ≥30% or ≥2-point reduction in VAS; non-responder: \\\u003C30% or \\\u003C2-point reduction). The primary analysis will compare baseline TAS-20 scores between responders and non-responders, evaluate correlations between alexithymia subdimensions and clinical changes, and identify independent predictors of treatment success through multivariable regression models adjusted for depression, anxiety, and baseline pain duration.","Patients presenting to the Algology outpatient clinic at Marmara University Pendik Training and Research Hospital with chronic low back pain who are clinically indicated and scheduled for Transforaminal Epidural Steroid Injection.",[36],{"label":37,"type":29,"description":38,"interventionNames":39},"Chronic Low Back Pain Patients Receiving TFESI","Adult patients aged 18 years or older with chronic low back pain with or without radiculopathy scheduled to receive clinically indicated fluoroscopy-guided Transforaminal Epidural Steroid Injection due to failure of conservative therapies",[40],"Other: Psychometric Assessment and Clinical Follow-up Battery",[42],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Psychometric Assessment and Clinical Follow-up Battery","Pre-procedural assessment (VAS, TAS-20, HADS, SF-12, CTQ-33, sociodemographic form) followed by longitudinal clinical evaluations at Week 1 (VAS), Month 1 (VAS, SF-12), and Month 3 (VAS, SF-12) post-TFESI",[37],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Konuralp Karbeyaz, MD","CONTACT","+905326209392","karbeyazkonuralp@gmail.com",{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100656615","effect-of-alexithymia-on-treatment-response-to-transforaminal-epidural-steroid-injections-in-chronic-low-back-pain-100656615",false,"NCT07828132","Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain","The Effectiveness of Transforaminal Epidural Steroid Injection in Patients With Chronic Low Back Pain and the Impact of Alexithymia on Treatment Response: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n1. Adults aged 18 years or older.\n2. Clinical diagnosis of chronic low back pain persisting for at least 3 months.\n3. Clinical indication and scheduled for Transforaminal Epidural Steroid Injection (TFESI) due to failure of conservative management.\n4. Literate and possessing sufficient cognitive capacity to understand and complete self-report instruments.\n5. Voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.\n2. Active psychotic disorder or current manic episode.\n3. Suspected acute self-harm or suicidal risk identified during clinical examination.\n4. Chronic back pain secondary to malignancy, acute fracture, or active local\u002Fsystemic infection.\n5. Severe active psychiatric illness currently undergoing medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).\n\n(Note: Depressive symptoms alone are not an exclusion criterion; they are systematically quantified via HADS and controlled for as covariates).","ALL","18 Years",{"count":64,"type":65},60,"ESTIMATED","OBSERVATIONAL","Low back pain and lumbosakral radiculopathy represent common clinical challenges substantially diminishing health-related quality of life and work productivity. Transforaminal Epidural Steroid Injection (TFESI) is widely performed in routine practice to reduce radicular pain, enhance functional capacity, and mitigate the need for surgery. However, clinical response to TFESI remains notably heterogeneous, indicating that biomedical parameters alone may not fully account for treatment efficacy and that psychosocial variables play a critical role.\n\nAlexithymia, defined as difficulty in identifying and describing emotions coupled with an externally oriented cognitive style, is prevalent among individuals with chronic spinal pain and linked to heightened pain perception and affective distress.\n\nThis prospective observational cohort study aims to investigate the influence of baseline alexithymia levels (measured by the 20-item Toronto Alexithymia Scale \\[TAS-20\\]) on treatment response (defined as pain relief and functional improvement) following routine clinically indicated TFESI in patients with chronic low back pain and radiculopathy.",[69,70,71],"Chronic Low Back Pain","Radiculopathy","Alexithymia",[73,74,69,75,71,76,77,78],"Transforaminal Epidural Steroid Injection","TFESI","Radicular Pain","TAS-20","Treatment Outcome","Quality of Life","NOT_YET_RECRUITING","2026-09-14",{"date":82,"type":83},"2026-09-18","ACTUAL",{"date":85,"type":65},"2026-09",{"date":87,"type":65},"2027-10",{"name":5,"class":6}]